Introduction to Good Manufacturing Practices- Charlottetown PEI
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  • Day 1November 27, 2019
    9:00 am - 5:00 pm
  • Day 2November 28, 2019
    9:00 am - 5:00 pm

Location

M QA QC RA

Certification Areas

This is an interactive 2-day course which provides a fresh dynamic and offers attendees alternative approaches to problem solving. In addition, hands on exercises enable participants to map their individual GMP responsibilities and gain the skills and knowledge necessary to understand and work in a GMP compliant environment and contribute to the ongoing quality of their company and organization. Last year, Health Canada released revised guidelines to the GMP Regulations which became effective in October 2018. This course will include and cover these updates.

 

Course Outline:

This 2-day course will cover the following topics:

 

  • – Introduction and Definitions
  • – Premises/building, Sanitation, Equipment and Personnel qualifications
  • – Developing a pharmaceutical quality system
  • – Raw material testing
  • – Manufacturing & Production Controls
  • – Finished product testing
  • – Quality Control Department & Laboratory Controls
  • – Packaging and Labelling Control
  • – Retain Samples and Stability
  • – Documentation, record keeping and Data Integrity

 

Regulations covered:

 

  • – Health Canada GUI-0001 Good Manufacturing Practices for Drug Products
  • – FDA part 211 Current Good Manufacturing Practice for Finished Products

 

Course Leader

Dr. Pauline McGregor, Ph.D. Chem, MRSC



Student Ticket: $250.00 Sold Out
Basic Member Ticket: $1100.00 Sold Out
Pro/Pro Plus Member Ticket: $1025.00 On Sale